Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-30 @ 9:44 PM
Study NCT ID:
NCT05446805
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression and Driving
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}, {'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma based biomarker', 'timeFrame': 'Each participant will complete a blood draw within their first year of participation.', 'description': 'Analyses of amyloid and tau burden among plasma samples'}, {'measure': 'Cerebrospinal fluid biomarker', 'timeFrame': 'Each participant will complete an optional lumbar puncture within their first year of participation.', 'description': 'Analyses of amyloid and tau burden among cerebrospinal fluid samples'}, {'measure': 'Amyloid PET-based biomarker', 'timeFrame': 'Each participant will complete a PET scan with radiotracer PIB within their first year of participation.', 'description': 'Amyloid measured by Pittburgh compound B'}, {'measure': 'Tau PET-based biomarker', 'timeFrame': 'Each participant will complete a PET scan with radiotracer AV1451 within their first year of participation.', 'description': 'Tau measured by AV1451'}], 'primaryOutcomes': [{'measure': 'Latitude via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'The latitude coordinate of the location of the vehicle being driven'}, {'measure': 'Longitude via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'The Longitude coordinate of the location of the vehicle being driven'}, {'measure': 'Vehicle Speed via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'The speed at which the vehicle being driven is moving.'}, {'measure': 'Speed Limit via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'The posted speed limit for the location that participant is driving.'}, {'measure': 'Difference via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'The difference between the speed at which the vehicle is moving and the posted speed limit for the location.'}, {'measure': 'Event Name via DRIVES Chip', 'timeFrame': 'Daily for up to five years', 'description': 'Name of the geofence in which participant had a driving event.'}, {'measure': 'Address via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Address of the location in which participant had a driving event.'}, {'measure': 'Event Type via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Enumeration describing the type of event: ignition on, heartbeat, ignition off, braking, acceleration, overspeeding, idling, low fuel, cornering, low battery event, diagnostic event triggered.'}, {'measure': 'Event Time via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Timestamp in GMT on which the event occurred.'}, {'measure': 'Odometer Reading via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Odometer reading of the vehicle.'}, {'measure': 'Trip Distance via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Total distance covered during the trip'}, {'measure': 'Peak Speed via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Highest speed attained by the vehicle during the trip.'}, {'measure': 'Average Speed', 'timeFrame': 'Daily for up to five years', 'description': 'Average trip speed of the vehicle.'}, {'measure': 'Initial Speed via DRIVES chip', 'timeFrame': 'Daily for up to five years', 'description': 'Speed at the beginning of the trip.'}, {'measure': 'Final Speed via DRIVES chip.', 'timeFrame': 'Daily for up to five years', 'description': 'Speed at the end of the trip.'}], 'secondaryOutcomes': [{'measure': 'Trail Making A', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.'}, {'measure': 'Trail Making B', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will test executive function.'}, {'measure': 'Montreal Cognitive Assessment (MoCA) Total', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.'}, {'measure': 'Category Fluency', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.'}, {'measure': 'Phonemic Fluency', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will test language ability.'}, {'measure': 'Mini Mental Status Exam', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will screen for cognitive impairment.'}, {'measure': 'Clinical Dementia Rating (CDR) Sum of Boxes', 'timeFrame': 'Annually for up to five years', 'description': 'This will be tested annually in a private office setting using paper and pen assessments. This will test for cognitive impairment/dementia severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Drive']}, 'descriptionModule': {'briefSummary': 'This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).', 'detailedDescription': 'The long-term goal is to accurately identify who is at risk of decline in driving, to forecast when decline will occur, and to intervene before decline, thereby reducing the numbers of crashes, injuries, and death in older adults. The findings indicate that the long preclinical stage of Alzheimer disease (AD), as reflected in amyloid imaging and cerebrospinal fluid (CSF) biomarkers among cognitively normal participants, is associated with poorer driving performance on a standardized road test. This project will assess how depression, preclinical AD, and antidepressants affect driving behavior in cognitively normal older adults (65 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '70 participants will create a depressed cohort in which they must be determined to have active major depressive disorder (MDD) as defined by psychiatrist, Dr. Eric Lenze.\n\n70 participants will be cognitively normal (CDR 0) or cognitively abnormal (CDR 0.5 or 1) but will be considered control cohort.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Drive on average at least once per week\n* Has a valid driver's license\n* Willing to complete blood draw\n* Willing to complete either lumbar puncture or PET imaging\n* 65 years or older\n* Speaks English\n\nExclusion Criteria:\n\n* Not willing to complete blood draw and/or one other biomarker\n* Less than 65 years of age\n* Does not drive a vehicle/ is no longer actively driving"}, 'identificationModule': {'nctId': 'NCT05446805', 'acronym': 'D&D', 'briefTitle': 'Depression and Driving', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'The Impact of Depression and Preclinical Alzheimer Disease on Driving Among Older Adults (Depression and Driving)', 'orgStudyIdInfo': {'id': '202003209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'depression', 'description': 'All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.', 'interventionNames': ['Drug: F 18 AV-1451 (Flortaucipir)', 'Drug: [11C]-Pittsburgh Compound B ([11C]PiB)']}, {'label': 'control', 'description': 'All participants will receive two one time PET scans with tracers AV1451 and PIB to detect tau and amyloid in the brain.', 'interventionNames': ['Drug: F 18 AV-1451 (Flortaucipir)', 'Drug: [11C]-Pittsburgh Compound B ([11C]PiB)']}], 'interventions': [{'name': 'F 18 AV-1451 (Flortaucipir)', 'type': 'DRUG', 'otherNames': ['AV-1451'], 'description': 'A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for \\[18F\\] AV-1451. A PET-certified medical professional will prepare and administer the \\[18F\\] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of \\[18F\\] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).', 'armGroupLabels': ['control', 'depression']}, {'name': '[11C]-Pittsburgh Compound B ([11C]PiB)', 'type': 'DRUG', 'otherNames': ['PIB'], 'description': 'A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for \\[11C\\] PIB. A PET-certified medical professional will prepare and administer the \\[11C\\] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of \\[11C\\] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.', 'armGroupLabels': ['control', 'depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samantha Murphy, MA', 'role': 'CONTACT', 'email': 'msamantha@wustl.edu', 'phone': '314-286-2435'}, {'name': 'Ganesh Babulal, PhD, OTD', 'role': 'CONTACT', 'email': 'babulalg@wustl.edu', 'phone': '(952) 334-8536'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Samantha Murphy, MA', 'role': 'CONTACT', 'email': 'msamantha@wustl.edu', 'phone': '(314) 286-2435'}, {'name': 'Ganesh Babulal, PhD, OTD', 'role': 'CONTACT', 'email': 'babulalg@wustl.edu', 'phone': '(952) 334-8536'}], 'overallOfficials': [{'name': 'Ganesh Babulal, PhD, OTD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ganesh Babulal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ganesh Babulal', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}